5.3 Compliance with national legislation regarding Adults unable to consent to themselves in a non-CTIMP

Introduction

Different national legislation applies across the UK in relation to the inclusion of Adults unable to consent for themselves in research. The main relevant differences in legislation across the UK are detailed below:

England and Wales

• The Mental Capacity Act 2005 applies

Scotland

• The Adults with Incapacity (Scotland) Act 2000 applies

Northern Ireland

• The Mental Capacity Act (Northern Ireland) 2016 applies

The Mental Capacity Act 2005 (MCA) provides a comprehensive framework (in England and Wales) for decision making on behalf of adults aged 16 and over who are unable to make decisions for themselves, i.e. they lack capacity. The Act applies to (amongst other things) any intrusive research within England and Wales, wherever it takes place, except for clinical trials of investigational medicinal products.

Different regulatory provisions apply in Scotland and Northern Ireland. In Scotland, the inclusion of adults lacking capacity in research is governed by the provisions of Section 51 of the Adults with Incapacity (Scotland) Act 2000. In Northern Ireland, the inclusion of adults lacking capacity in research is governed by the Section 132 provisions of the Mental Capacity Act (Northern Ireland) 2016. As the acts that apply in Northern Ireland, England and Wales are closely aligned, a scheme of mutual recognition of NHS/HSC research ethics committee (REC) review for research involving adults lacking capacity to consent has been agreed between these three nations.

The study-wide reviewer will be responsible for considering the study according to the national legislation of their nation alone. However, the study-wide reviewer must highlight to the other participating UK nations where there are differences in legislation that will need to be considered.

REC Favourable Opinion

In England, Wales, and Northern Ireland approval must be sought from an ‘Appropriate body’. To be considered an ‘Appropriate body’ for purposes of England and Wales a REC must be recognised by the Health Research Authority. To be considered an ‘Appropriate Body’ for purposes of Northern Ireland, a REC must be named within the Mental Capacity (Research) (Amendment) Regulations (Northern Ireland) 2020.

As the Mental Capacity Act (Northern Ireland) 2016 and the Mental Capacity Act 2005 (which applies in England and Wales) closely align, a scheme of mutual recognition of NHS/HSC REC review for research involving adults lacking capacity to consent has been agreed between these three nations. This means that a research project involving adults lacking capacity to consent and with sites in England/Wales and Northern Ireland only requires one NHS/HSC REC review as long as the REC is considered an ‘Appropriate Body’ for the purposes of both England/Wales and Northern Ireland.

In Scotland approval under the Adults with Incapacity (Scotland) Act must be sought from the Scotland A REC.

In the case of studies taking place at participating NHS/HSC organisations in both Scotland and another UK nation an application must be made to both Scotland A REC and another REC recognised for the purpose in either England, Wales or Northern Ireland. The study may commence (assuming all other relevant approvals are in place) once favourable opinion is given by the REC in the relevant jurisdiction (for example the study may commence in Scotland once favourable opinion has been granted by Scotland A REC without waiting for favourable opinion from the other reviewing REC). It should be noted that where a study proposes to recruit Adults Lacking Capacity only in Scotland (or only in England/Wales/Northern Ireland) then only a single REC application is required, which should made in either Scotland, or England/Wales/Northern Ireland, based on where Adults Lacking Capacity will be recruited.

The Sponsor should provide the following relevant to enable the reviewing REC to consider:

1. whether the research is connected with an impairing condition affecting research participants who are unable to consent, or with the treatment of the condition. An impairing condition means a condition which is attributable to (or causes or contributes to) an impairment or disturbance in the functioning of the mind or brain
2. whether or not the research could be carried out as effectively if it was confined to research participants able to give consent, i.e. is it necessary to include research participants lacking capacity in order to meet the research objectives?
3. the proposed arrangements to identify, consult and provide information to consultees and/or legally appropriate representatives
4. (in the event of recruitment in an emergency setting in England, Wales and Northern Ireland), whether this is justified in the circumstances and whether the research team have appropriate procedures in place to seek consent from a capable research participant (if recovered) or to consult a consultee as soon as practicable after urgent treatment has been provided
5. whether the research is of potential benefit to research participants lacking capacity without imposing a disproportionate burden, OR, whether the research is intended to provide knowledge of the causes or the treatment or care of the condition affecting participants lacking capacity or of a similar condition, and additionally:

a) the risk to participants is likely to be negligible [22]

b) the research will not significantly interfere with their freedom of action or privacy

c) the research will not be unduly invasive or restrictive

1. whether they are satisfied that arrangements are in place to ensure that

a) nothing will be done:

i) to which research participants lacking capacity appear to object (unless it is to protect them from harm or reduce/prevent pain or discomfort)

ii) which would be contrary to any known advance decision or statement they have made

b) if research participants indicate in any way that they wish to be withdrawn from the project, they must be withdrawn without delay, except where this involves stopping treatment and there could be a significant risk to their health

c) the interests of research participants will be assumed to outweigh those of science and society

Provision of advice from consultees and receiving consent from Legal representatives

The process for identification of, and provision of information to, consultees (in England, Wales and Northern Ireland) and/or Legal representatives (in Scotland) should be clearly explained by the sponsor who should ensure that this complies with the requirements of the common law duty of confidentiality.

The MRC ethics guide ‘Medical research involving adults who cannot consent’ (2007) notes that, whilst incentives or financial inducements should not be used, MRC policy is that, as in other research, payment of legitimate expenses of participants or representatives directly related to participation in the trial is generally considered acceptable.

In England, Wales and Northern Ireland

In England, Wales and Northern Ireland advice should be sought from consultees regarding whether an adult lacking capacity to consent would wish to be included in the proposed study. The Mental Capacity Act does not specify a hierarchy. It is a matter of judgment for the researcher, in consultation with the participant’s care team, to identify the most appropriate person. This will normally be the participant’s usual carer, or another person closely concerned with their welfare. This may or may not be the nearest relative.

Consultees are not asked to give consent on behalf of the adult. Consultees are asked to provide an opinion on the views and feelings of the potential participant. The term assent or consent must therefore not be used in any study paperwork in the context of seeking advice from consultees. A consultee may be either a personal consultee (i.e. a person who cares for the adult lacking capacity or is interested in that person's welfare, but is not doing so for remuneration or acting in a professional capacity) or, if no personal consultee is available, a nominated consultee may be approached (i.e. a professional who is independent of the study).

While there is no statutory requirement for the consultee to sign a form, but it is strongly recommended that the researcher uses a Consultee Declaration Form to confirm that the consultee has received the information, has had the opportunity to ask questions and has advised they have no objection to the participation of the person lacking capacity. Where carers will also be recruited as research participants in their own right, the information sheet should distinguish clearly between the two roles and the carer should sign a consent form separate from the consultee declaration sheet.

Where the study is happening in Northern Ireland, England and/or Wales both Acts should be referenced in the study paperwork and ‘For use in England, Wales and Northern Ireland’ should be made clear in relevant study paperwork, e.g. protocol, Consultee information sheet, Consultee Declaration form, etc. Where the study is happening in Northern Ireland only, the Mental Capacity Act (Northern Ireland) 2016 should be referenced in the study paperwork and ‘For use in Northern Ireland’ should be made clear in relevant study paperwork, e.g. protocol, Consultee information sheet, Consultee Declaration form, etc.

Where the sponsor significantly amends the study protocol, or otherwise plans to obtain further consent from participants then advice must be sought from consultees on behalf of any adults who have lost capacity.

Consultees must be:

• told that they are being asked to advise on the views and feelings they believe the adult would have towards participation in the research
• told that they are free to decide whether they wish to provide this advice or not
• given sufficient information, in an understandable form, about the research to ensure that they can provide informed advice

In Scotland

In Scotland a legal representative must asked to give consent on behalf of an adult who lacks the capacity to do so themselves. Those who are able to act as a legal representative in research other than Clinical Trials of Investigational Medicinal Products (i.e. non-CTIMPs), in Scotland are:

• adult's Welfare Guardian or Welfare Attorney
• the adult's nearest relative (as defined by the Adults with Incapacity (Scotland) Act) [21] (if an Adult's Welfare Guardian or Welfare Attorney has not been appointed)

The legal representative must be:

• told that they are being asked to give consent on behalf of the incapacitated adult
• told that they are free to decide whether they wish to make this decision or not, and
• told that they are being asked to consider what the adult would want, and to set aside their own personal views when making this decision
• given sufficient information, in an understandable form, about the trial to ensure that they can make an informed decision

Provision of Information to participants who lack capacity

Even if they are unable to consent for themselves participants should be provided with information about the study, its risks, and benefits, according to their capacity of understanding. Nothing may be done to which a participant appears to object (whether by showing signs of resistance or otherwise) except where what is being done is intended to protect him from harm or to reduce or prevent pain or discomfort. If, at any time the participant expresses a view, in any way (which may not necessarily be verbally) that they do not wish to take part in the research, this view must be acted upon.

Participants regaining capacity during the study

If it is considered likely that adult participants might regain capacity during the course of the research the sponsor should plan for how they will be involved in the ongoing consent process. In most cases it will be most appropriate to provide information on what has happened while they lacked capacity and to ask them to consent to their continued participation in the research (including giving them the option to withdraw themselves and their previously collected data from the research). The research team should

• inform the legal representative (in Scotland) or consultee in (England/Wales and Northern Ireland) of this possibility at the outset and explain what processes you will follow in the event of a participant regaining the capacity to consent
• provide an appropriate Participant Information Sheet and consent form for participants that explains what has happened to date and what consent is now sought for
• plan for how a situation where a participant withdraws consent will be handled

Participants that lose capacity during participation in research

In England and Wales

A core principle of the Mental Capacity Act 2005 is that capacity should be assumed unless established otherwise. If a participant has consented to take part, it may generally be assumed that capacity remains in place, but the researcher should be alert to any changes suggesting that capacity has been lost. Where it is considered likely that capacity will be lost during the course of the research the sponsor should explain what monitoring arrangements they will put in place.

Where capacity is established to have been lost, and it is the intention of the research team that the participant would remain in the study and would be required by the protocol to undergo further interventions and procedures that constitute ‘intrusive research’ then approval by a recognised REC should be sought and advice should from consultees obtained (following the processes detailed above). Where consent has been obtained prior to loss of capacity and the participant gave specific consent to use previously collected samples and data following loss of capacity, these may be retained in identifiable form if this is necessary for the research.

In situations where the potential for losing capacity was discussed as part of the original consent then advice from consultees is still required when considering whether to continue to involve the relevant participant in the study. The original consent given by participants should not automatically be considered absolute (although consultees would be expected to give regard to it) and the current circumstances of the participant must be considered.

In Scotland

Legally there is no specific provision for adults who lose capacity while taking part in non-CTIMPs in Scotland. Therefore, in most circumstances the original consent should be respected. However, a request by a legal representative to withdraw someone from a study after they have lost capacity, should be considered carefully to ensure that it reflects the wishes of the person before they lost capacity, and that their current situation is fully considered, including possible benefits and harms that might arise as a consequence of their continued participation.

Where the sponsor significantly amends the study protocol, or otherwise plans to obtain further consent from participants then advice must be sought from consultees on behalf of any adults who have lost capacity.

In Northern Ireland

A core principle of the Mental Capacity Act (NI) 2016 is that capacity should be assumed unless established otherwise. If a participant has consented to take part, it may generally be assumed that capacity remains in place, but the researcher should be alert to any changes suggesting that capacity has been lost. Where it is considered likely that capacity may be lost during the course of the research the sponsor should explain what ongoing arrangements they will put in place to monitor this.

Where capacity is established to have been lost, and it is the intention of the research team that the participant would remain in the study and would be required by the protocol to undergo ‘intrusive research’ then, for the purposes of the Mental Capacity Act (NI) 2016, the study must undergo review by an appropriate body (a research ethics committee named in the regulation) and advice from the participants consultee regarding their ongoing participation is required.

Where consent has been obtained prior to loss of capacity and the participant gave specific consent to use previously collected samples and data following loss of capacity, these may be retained in identifiable form if this is necessary for the research.

In situations where the potential for losing capacity was discussed as part of the original consent process then advice from consultees is still required when considering whether to continue to involve the relevant participant in the study. The original consent given by participants should not automatically be considered absolute (though consultees would be expected to give regard to it) and the current circumstances of the participant must be considered.

Emergency Research

In England, Wales and Northern Ireland

In England, Wales and Northern Ireland the law allows adults not able to consent for themselves to be recruited without prior advice from a consultee if:

1. treatment needs to be given urgently, and
2. it is not reasonably practicable to seek advice from a consultee, and
3. the procedure is approved by a recognised REC, and
4. a consultee is consulted as soon as possible to seek advice on the participant's likely views and feelings

If adults recruited in such a manner regain their capacity to consent, then the provisions provided above should be followed. Should an individual recruited in such a manner die before advice can be sought from a consultee the sponsor should consider its position in relation to the Common Law duty of Confidentiality. If the research, in an emergency setting, can be considered as only option (among several) by which care can be provided then the processing of identifiable patient data for the purpose of delivering that care is covered by the legal basis of necessity. The sponsor should consider whether, further processing for research purposes, for example completion of CRF’s requires the processing of personal identifiable data, or whether such processing can be conducted using data which is only identifiable to the care team (and otherwise anonymised such that the Common Law duty of Confidentiality no longer applies). Where this is not possible the sponsor should explain what alternative legal basis will be relied upon.

In Scotland

In Scotland the law does not provide any 'exemptions' or alternatives for the involvement of adults not able to consent for themselves in non-CTIMP research, even in emergency situations. Therefore, appropriate consent must be sought, as detailed above, before an adult can be involved in the research.

Assessment of capacity

Study wide review should ascertain that protocol has appropriate processes in place for who will make the decision on whether participants have capacity to consent for themselves. The protocol should detail whether the PI will themselves make this assessment or whether this will be delegated to members of their research team. In England and Wales The Mental Capacity Act Code of Practice states that ‘The person who assesses an individual’s capacity to make a decision will usually be the person who is directly concerned with the individual at the time the decision needs to be made’. the assessor ‘must have a ‘reasonable belief’ that the person lacks capacity to agree to the action or decision to be taken’ but there are no specific requirements that assessor be trained or qualified in any specific respect. Rather, when making their assessment, the assessor should take account of the Code of Practice suggestions regarding the factors that should be taken into account, and how these factors might be considered.

Study-wide considerations

• has the sponsor made provision for appropriate ethical review, considering the UK nations in which the study will take place?
• has relevant information been provided by the sponsor to enable the REC to effectively and appropriately review the study?
• does the process for the identification of legal representatives and/or consultees comply with the common law duty of confidentiality?
• has the sponsor made appropriate arrangements for the provision of information to consultees (in England, Wales and Northern Ireland), and/or legal representatives (in Scotland) and has appropriate documentation been provided for this purpose?
• has the sponsor explained what information will be provided to participants, according to their capacity of understanding? Where the sponsor does not propose to provide any such information an appropriate justification should be provided
• has the sponsor made arrangements to offer any incentives or financial inducement to the participant or their legal representative? If so, except in the case of provision for compensation in the event of injury or loss. study wide reviewers should challenge this as such payments are discouraged, except where explicitly approved by the REC
• has the sponsor made appropriate arrangements for how a situation where an adult participant regains capacity will be handled (if applicable)?
• where applicable has the sponsor made appropriate, nation specific, arrangements for how they will address a situation where a participant, who previously provided consent to participate in the research, loses capacity to consent for themselves, including with respect to the provision of relevant documentation
• has the sponsor made arrangements if they plan to obtain further consent from participants, to seek further advice from consultees (in England, Wales and Northern Ireland) or Legal representatives (in Scotland) on behalf of any adults who have lost capacity?
• where the sponsor proposes to recruit in an emergency setting
  • (in England, Wales and Northern Ireland) has the sponsor
    • explained why this is necessary
    • sought review from a REC recognised as an ‘Appropriate Body’
    • made appropriate arrangements to seek advice from consultees as soon as possible following the emergency
    • explained how data will be processed in accordance with the common law duty of confidentiality, particularly in circumstances where the participant dies before consultee advice can be obtained
  • in Scotland has the sponsor explained how consent will be sought from legal representatives before commencing research procedures